Bayer's Biologic Betaseron (Interferon Beta 1B) Receives Approval in the U.S.
Novartis Pharms's Biological Interferon Beta-1B Receives Approval In US
Bayer Healthcare Pharms's Biological Interferon Beta-1B Receives Approval In US
Novartis has reported that the Phase III ASCLEPIOS I and II clinical trials of ofatumumab (OMB157) have met the primary endpoints in adults suffering from relapsing forms of multiple sclerosis (RMS).
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WHIPPANY, N.J., Dec. 17, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved the inclusion of new safety data on pregnancy in the prescribing information for Betaseron® (Interferon beta 1b, IFNß-1b), which is indicated for the treatment of relapsing remitting multiple sclerosis (RRMS). The label update is based on prospective data collected from U.S. and international pregnancy exposure registries and is in accordance with the FDA's Pregnancy and Lactation Labeling Rule (PLLR).
Novartis Pharm's Biological Interferon Beta-1B Receives Approval in US